Polarean Imaging Share Discussion Threads

[hedgehog 100] 27/5/2020 15:41

FDA approval is in effect a licence to sell in the US, which should open the door to a quite enormous market for POLX. More than thirty million Americans suffer from a chronic lung disease: 29/01/2020 07:00 UK Regulatory (RNS & others) Polarean Imaging PLC Positive pivotal Phase III Clinical Trials results " ... Richard Hullihen, Chief Executive Officer of Polarean said: "The positive results of these Clinical Trials validate our belief that Polarean's technology allows clinicians to visualise aspects of the lung function, which have never before been visible by MRI, both safely and quantitatively. More than 30 million Americans suffer from a chronic lung disease and the financial burden of lung disease now exceeds US$150 billion annually. Given the limitations of existing methods to diagnose and monitor lung disease, we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnosis technology without exposing patients to ionizing radiation. We believe that our technology has the potential to overcome these limitations and we look forward to using data from the Clinical Trials to support our New Drug Application." ... " https://uk.advfn.com/stock-market/london/polarean-imaging-POLX/share-news/Polarean-Imaging-PLC-Positive-pivotal-Phase-III-Cl/81619744

[hedgehog 100] 27/5/2020 15:29

Hedgehog 100 16 May '20 - 19:27 - 394 of 398 Edit 0 4 0 " ... In addition, you tend to find that a share price will appreciate a lot during the FDA approval process, in anticipation of the approval. ..." A good relatively recent example is Shield Therapeutics (STX). STX rose about six-fold in the first seven months of last year, from about 30p, until just after its FDA approval on 26th. July 2019. And it more than trebled during this period ahead of the FDA approval, before enjoying a very strong rise at the FDA approval itself. 26/07/2019 07:00 UKREG Shield Therapeutics PLC FDA approves Feraccru® with a broad label "London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Feraccru(R) / Accrufer(R) for the treatment of iron deficiency in adults. With this broad label approval Accrufer(R) (as the product will be marketed in the USA) has taken a big step towards exploiting the very large commercial opportunity in the USA, the world's largest and most attractively reimbursed pharmaceutical market. Market research suggests that the prescription market for iron replacement therapy in the USA is worth over $1.0bn annually. There are between 8 million and 9 million patients in the USA who suffer from iron deficiency anaemia and management estimate potentially two to three times this number require treatment for iron deficiency. ..." https://uk.advfn.com/stock-market/london/shield-therapeutics-STX/share-news/Shield-Therapeutics-PLC-FDA-approves-Feraccru-wit/80405106

[yasrub] 25/5/2020 07:52

Covid-19 the reality seems to be setting in that a vaccine is unlikely for some significant time,if ever. Always easy to then put forward a company that you are invested in believing their tech will help - charged as guilty! POLX surely will be in a position ST and LT to be in demand - Based on the history of Jonathan Allis he might know his way around of how to achieve this.

[diversification] 20/5/2020 17:29

Nice post HH, the story here is very compelling and the deeper you research the better the story gets.

[hedgehog 100] 20/5/2020 17:05

Remember that just under a year ago Bracco Imaging acquired a similar company to POLX: Blue Earth Diagnostics ... for $450M. "Blue Earth Diagnostics sold to Bracco Imaging in $450M deal by Conor Hale | Jun 27, 2019 11:57am Molecular PET agent developer Blue Earth Diagnostics has been picked up by the Italian multinational Bracco, which will take in the company as a subsidiary under its medical imaging banner. Blue Earth’s previous owner, the London-based healthcare group Syncona, traded its outstanding shares in the company to Bracco for $450 million, plus an estimated closing adjustment of $25 million. ..." HTTP://www.fiercebiotech.com/medtech/blue-earth-diagnostics-sold-to-bracco-imaging-450m-deal Thanks to McFly for these comments about that acquisition: Mcfly795 Jan '20 - 12:04 - 173 of 395 " ... Over $50m has been spent on the development of the product, much by GE before Polarean acquired it. . To see where the company could go it's worth looking at a company called Blue Earth Diagnostics. . Very similar business to Polarean. They are a UK imaging device company that developed a novel imaging agent for PET scans to help with prostate cancer imaging (whereas Polarean has developed a novel imaging agent for MR scans for Pulmonary imaging). . Like Polarean the technology was pulled out of GE. . From being formed in 2014 the company was sold in June 2019 for $450m to an Italian imaging business. Polarean is valued at $35m. . As if there weren't enough similarities, the founder and CEO of Blue Earth Diagnostics is Jonathan Allis, who is a non-executive director of Polarean and very active in the business. Jonathan Allis bought 1,540,000 shares in Polarean in October as part of the Amphion buy out. . It may take a year before we receive FDA approval but I think there is the potential for corporate action in that time, such as a partnership with a very large MR device manufacturer. . Interestingly the Blue Earth Diagnostics FDA approval only took 6 months under a priority review: . hTTp://www.blueearthdiagnostics.com/siemens-petnet-solutions/ hTTp://www.blueearthdiagnostics.com/u-s-fda-approves-blue-earth-diagnostics-axumintm-fluciclovine-f-18-injection-priority-review-pet-imaging-recurrent-prostate-cancer/ ... "

[hedgehog 100] 16/5/2020 19:48

Also, there's a lot of potential near-term positive newsflow in the pipeline in addition to the FDA approval process. Thanks to diversification for this excellent summary: diversification 28 Apr '20 - 15:39 - 358 of 394 0 3 0 "News pending (IMO) Today 10:17 - Sale of additional Polarizers (min 3) - Read out from AstraZeneca Phase 3 study - Bracco Imaging international expansion/approval - Big Pharma collab - Potential scientific user application related to COVID19 - Pre-NDA meeting imminent - NDA submission With the share price at 24p we are at a pivotal point. If we breakout today (L2 1v3) with more volume, this tightly held stock could head back towards its ATH with plenty of justification. Fully funded through to FDA approval their will be plenty of newsflow, some of which I haven’t even mentioned, and with a £40m market cap their isn’t a sector I would rather be in than pulmonary imaging right now!"

[hedgehog 100] 16/5/2020 19:27

RichardJohn1014 May '20 - 18:16 - 390 of 393 0 1 1 "FDA is a year away so why are you investing now? I’m just curious?" Richard, In a sector where it can take a decade or more to bring a drug to market, a year will be regarded as pretty close by most investors. And it could potentially be a lot sooner than a year: say 6 months or so for a priority review ... and even faster than that if it's fast-tracked for the COVID-19 benefit. In addition, you tend to find that a share price will appreciate a lot during the FDA approval process, in anticipation of the approval. And remember that with its recent fundraising POLX is fully-funded for the FDA approval process ... and that there's not the same real risk of rejection as with drugs, where there can be unpleasant side effects. "Priority review From Wikipedia, the free encyclopedia Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. ..." https://en.wikipedia.org/wiki/Priority_review "Fast track (FDA) From Wikipedia, the free encyclopedia Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. ..." https://en.wikipedia.org/wiki/Fast_track_(FDA)

[buywell3] 15/5/2020 06:48

Girls buywell notes your comments More iron might help DOW to 15000 next leg down is buywells' call , super might know that Being an ardent fan

[richardjohn10] 14/5/2020 18:16

FDA is a year away so why are you investing now? I'm just curious?

[diversification] 14/5/2020 17:52

I actually cringed at it, haven’t filtered he/she as it will be hard to rock the boat here and I didn’t have to pay for that laugh. Earlier today it took 45 minutes to execute my order at 26p, news is imminent imo

[supernumerary] 14/5/2020 17:15

He does it all the time. It's his usual modus operandi - he wants to buy, so starts with this sort of nonsense trash talk to try and get the price down. When he's happily on board, the story suddenly changes... Wouldn't take too much notice - it's just noise in the greater scheme of things.

[diversification] 14/5/2020 16:55

Did you really just refer to yourself in third person?

[buywell3] 13/5/2020 23:58

buywell is of the opinion that when the USA next leg down Kicks off in earnest Which should coincide with another Covid wave worldwide And USA 2nd lockdown Which timewise could be peak wave at middle of august (4 months between peaks) The hot money will evaporate like the first leg down Chartwise 16.5p retest IMO likely from the chart with a possible 14p visit this time IMO dyor

[richardjohn10] 13/5/2020 23:00

Over a year for FDA. I'll be back at a later stage

[richardjohn10] 13/5/2020 21:42

Cheers for that

[mcfly79] 13/5/2020 21:12

The timeline is as follows: Pre-submission meeting due in Q2 this year FDA submission expected in Q3 this year FDA approval expected in Q3 2021. There may be an opportunity to accelerate the approval process.

[richardjohn10] 13/5/2020 20:57

Will FDA be this year or early next?

[richardjohn10] 13/5/2020 13:02

Will do gaffer just wanted quick recap

[diversification] 13/5/2020 12:58

If you have any significant interest in this stock I would read this board and the other board, L. S. E. over the last 4 weeks and you will have all you need to know. Significant pipeline of news for a company who images Pulmonary function. Unmet need.

[richardjohn10] 13/5/2020 12:24

Will it be FDA approved this year?

[idiot441] 13/5/2020 11:57

FDA news of meeting due any day... in may

[richardjohn10] 13/5/2020 11:29

When's FDA due here please? What's keeping current MCAP up?